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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 2  |  Page : 71-76

Transcription factor Runx2 in necrotic femoral head tissue: study protocol for a retrospective non-randomized parallel-controlled trial


Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China

Correspondence Address:
Li-qing Yang
Shengjing Hospital of China Medical University, Shenyang, Liaoning Province
China
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Source of Support: This work was supported by a grant from High-Tech Research and Development Program of Liaoning Province of China, No. 2009225010-15., Conflict of Interest: None


DOI: 10.4103/2468-5658.184747

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Background: Osteonecrosis of the femoral head (ONFH) results from an interruption of the blood supply to the femoral head or injury-caused death of chondrocytes and bone marrow components. Many osteogenesis-related factors, such as Runt-related transcription factor 2 (Runx2), bone morphogenetic protein (BMP), osteoprotegerin and osteocalcin, are involved in the subsequent repair process. Runx2 is an important transcription factor responsible for osteoblast differentiation and maturation of bone marrow stromal stem cells during bone development. The Runx2 gene has been shown to control osteoblast differentiation and formation by upregulating the transcription of various mineralization-related protein genes in chondrocytes, allowing chondrocyte differentiation into osteoblasts, and playing a key role in bone repair. Methods/Design: A retrospective, single-center, non-randomized, parallel-controlled trial was performed at Shengjing Hospital of China Medical University, China. Fifteen patients with ONFH and 15 patients with osteoarthritis were scheduled to undergo total hip replacement. Primary measure is Runx2 messenger RNA (mRNA) expression in femoral head and neck tissue, and secondary measures include BMP-2, BMP-7 and osteoprotegerin mRNA expression, as well as osteocalcin immunoreactivity. Discussion: During 2010-2011, this study first detected mRNA expression of several bone repair-related genes, including Runx2, in the femoral head and neck of patients with ONFH. Runx2 expression was compared with that of bone tissue from osteoarthritis patients to identify expression in necrotic femoral head tissue, which help clarify the role and possible clinical significance of Runx2 in femoral head necrosis, bone repair and reconstruction. Trial registration: This trial was registered at ClinicalTrial.gov identifier: NCT02735538. Ethics: This study protocol was approved by the Ethics Committee of Shengjing Hospital of China Medical University (approval No. 2016PS222K) and was performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from each included patient.


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